Kornimate/medical-research-clean huggingface dataset:
effects of chemotherapy on circulating tumor cells and recurrences in cervical cancer patients

Conditions: Cervical Cancer

Summary: cervical cancer is a major health problem for chinese women. it is estimated that nearly 100,000 new cervical cancer cases occur in china every year, which accounts for about 20 percent of global new cases. surgery and radiotherapy are two major radical treatment methods for ib-iib cervical cancer. unlike the united states and some other countries, most of operable women with ib-iib cervical cancer received radical surgery other than radiotherapy in china. patients with recurrence risk factors (lymph node metastasis, deep stromal invasion, positive lymphatic vascular space, et al. ) also received adjuvant therapy after surgery, such as radiotherapy or chemoradiotherapy that are recommended in the nccn guidelines. however, in china a substantial part of patients especially those admitted to tertiary hospitals received several courses of chemotherapy instead of radiotherapy if they had recurrence risk factors . in our previous study, we found that patients with intermediate risk factors (deep stromal invasion, positive lymphatic vascular space, bulky tumor\>4cm) had better disease-free survival and recurrence-free survival when they received chemotherapy compared with radiotherapy. the objective in this study is to investigate whether the advantage of postoperative chemotherapy is a result of circulating tumor cells (ctc) in some of the patients with intermediate risk factors.


Eligibility criteria:
inclusion criteria: * patients with histologically confirmed ib\~iia （figo）cervical carcinoma without previous treatments * age between 18-70 * with the presence of these three pathological risk factors after radical surgery:(1) positive lymphatic vascular space,(2)outer one-third invasion of the cervical stroma, (3) bulky tumor≥4cm * at least 3 months of disease-free survival exclusion criteria: * the presence of other uncontrolled life-threatening disease (suffering from myocardial infarction or stroke, or unstable angina, decompensated heart failure, or a history of deep vein thrombosis) * receiving other anti-cancer therapy, such as traditional chinese drug * don't be able to finish the whole treatment(chemotherapy or radiotherapy) * liver dysfunction (alt、ast\>2.5×uln) * renal dysfunction (creatinine\>1.5×uln) * wbc\<4,000/mm3 or plt\<100,000/mm3 * received preoperative radiotherapy

Keywords: cervical cancer
the effect of the stress ball used during spinal anesthesia on pain and anxiety

Conditions: Pain; Anxiety

Summary: the aim is to determine the impact of the stress ball used during spinal anesthesia on pain and anxiety levels

our planned study, which is intended to be conducted as a prospective randomized controlled trial, will include patients aged 18 and above who fall into category 3 and 4 according to the classification used in the study by lucas et al., and who are undergoing cesarean section.patient data including age, weight, height, body mass index (bmi), asa (american society of anesthesiologists) score, gravidity, parity, history of abortion, gestational age, medical history, and surgical history will be recorded.the anxiety status of patients will be recorded using the state anxiety inventory (stai-i) score both before and after the procedure.patients will be divided into two groups using a randomization method. one group will be provided with a stress ball to squeeze during the administration of spinal anesthesia, while the second group will undergo spinal anesthesia without receiving a stress ball.all patients will receive intrathecal injection of 0.05% bupivacaine using a 25-gauge spinal needle. the visual analog scale (vas) will be assessed and recorded during the procedure to evaluate the patients' pain status.additionally, the patient's blood pressure, pulse, and saturation levels will be recorded before starting the procedure and 2 minutes after the procedure initiation. patient satisfaction will be evaluated after the procedure.

Eligibility criteria:
inclusion criteria: * patients aged 18 and above. * patients with cesarean category 3 and 4. exclusion criteria: * patients under the age of 18 * patients undergoing emergency cesarean section * patients with bleeding disorders * individuals with psychological disorders

Keywords: stress spinal anesthesia
comparing acute and continuous drug abuse treatment: a randomized clinical trial

Conditions: Drug Addiction

Summary: the purpose of this 2 year study is to conduct a fully powered effectiveness trial comparing recovery trajectories of 200 drug dependent adults (the subjects) who will be randomly assigned to treatment as usual (tau) or tau + long-term recovery management (ltrm).

drug addiction is a chronic illness characterized by problematic drug use, followed by periods of abstinence, reductions in use, or return to problematic drug use. despite this, substance abuse treatment has traditionally been based on an acute care model. the field needs an addiction management model for drug-dependent patients, which, like disease management for other chronic conditions, provides: 1) initial stabilization; 2) ongoing treatment to maintain clinical gains; 3) monitoring of patient symptoms; and 4) adjustments to the treatment based on the patient's response. in response to these needs we have developed the long term recovery management (ltrm) model. ltrm is predicated on initiating long-term addiction management at the onset of substance abuse treatment, extending the length of treatment, expediting the transitions between intensive treatment and maintenance of behavioral change, adapting treatment intensity to patient's response to treatment, and actively facilitating the therapeutic alliance. ltrm combines 3 established treatment techniques (community reinforcement approach, contingency management, and facilitated therapeutic alliance), each with demonstrated efficacy, into a chronic disease model. in addition, patient cases are kept open, thereby removing potential obstacles to re-engagement with stepped-up care, when indicated. the ltrm model emphasizes: engagement in continuous long-term treatment and recovery support, therapeutic alliance, and early re-intervention as the main mechanisms for maintenance of behavioral change.

Eligibility criteria:
inclusion criteria: to be eligible for the study, a subject must: * at least 18 years of age * meet current dependence criteria for stimulants (cocaine/other), opioids (heroin/other), and/or alcohol (if also dependent on cocaine or opioids). persons who are opioid dependent are eligible if they are not in methadone maintenance therapy; they will be eligible if they are in short-term buprenorphine detoxification * self-report use of a primary drug of dependence in the past 60 days; 4) be admitted to outpatient care at maryhaven * willing to participate in the protocol (i.e., to be randomized to treatment condition and agree to attend regular treatment sessions). exclusion criteria: * potential subjects will be excluded if they: 1) present with current suicide risk * have a current, untreated psychotic disorder * plan to relocate outside of the area within 12 months * have been sentenced to incarceration of more than 30 days over the next 6 months * are alcohol dependent without current dependence on cocaine or opioids.

Keywords: cocaine crack heroin non-prescribed opioids contingency management community reinforcement approach facilitated therapeutic alliance chronic disease treatment models
feasibility of eras protocol in t4 colorectal cancer patients

Conditions: T4 Colorectal Cancer; ERAS; Colon Cancer; Fast Track Protocol

Summary: patients diagnosed with t4 colorectal cancer represent a specific subgroup of colorectal patients, frequently composed of fragile patients whose advanced nature of the disease often requires a multi organ resection by an open surgery approach and frequently leads to higher intra/postoperative complication.those characteristics makes them to be considered less suitable for eras protocol, especially regarding an expected difficult compliance to postoperative items. the impact of enhanced recovery program on postoperative outcomes in this subset of patients has never been addressed in literature, in fact most of studies either excluded t4 patients due to higher rates of complication or adopted an homogeneous patient sampling analizing all stage colorectal cancer together. our aim is to investigate the feasibility of eras protocol in t4 colorectal patient, primary outcome was to compare postoperative lenght of stay between t4 colorectal patients treated with eras protcol and those treated with standard of care.


Eligibility criteria:
inclusion criteria: * colorectal cacer * hystologic diagnosis of adenocarcinoma of the colon/rectum * clinically staged t4 * written informed consent to surgery obtained exclusion criteria: * pregnancy * failure to perform colonic or rectal resection * synchronous cancer at time of colorectal cancer diagnosis

Keywords: colon cancer eras fast track t4 colorectal cancer colorectal cancer
early palliative care integration in interventional cancer care

Conditions: Palliative Care; Cancer Liver; Cancer Colon

Summary: a mixed methods randomized control trial assessing the impact of early palliative care incorporation in liver cancer and metastatic colorectal cancer on caregiver well-being, patient physical and psychosocial outcomes, and health services utilization.

the purpose of this project is to conduct a mixed-methods study of the impact of early integration of palliative care in interventional oncology on three outcomes of interest: 1) caregiver well-being, 2) patient physical and psychosocial outcomes, and 3) health services utilization and costs. palliative care focuses on providing patients with serious illnesses and their families with physical, emotional, social, practical, and spiritual support. recent trials examining the integration of palliative care in cancer care have individually shown improvement in patient symptoms and quality of life, reduction of caregiver burden, and/or health services costs. these studies, however, have not collectively analyzed these impacts.further, a recent study shows that integrating palliative care early in lung cancer care has proven beneficial to both patients and caregivers. given the potential of this previous body of research, the proposed study offers a comprehensive analysis of the early integration of palliative care on caregiver well-being, patient's physical and psychosocial outcomes when living with liver and metastatic colorectal cancer (mcrc), and health services utilization. this study thus broadens the scope to additional cancer types and degrees of progression.

Eligibility criteria:
inclusion criteria: - patients over 18 years of age with a confirmed diagnosis of liver cancer or metastatic colorectal cancer requiring treatment from the ir team. exclusion criteria: - none

Keywords: quality of life caregiver quality improvement
diagnosis of vertigo with new imaging

Conditions: Vertigo

Summary: the purpose of this study is to determine the potential usefulness of new functional mri in diagnostic assessment of patients presenting with vertigo.

the incidence of vertigo has been reported to be as high as 1.5% in the general population and some reports suggest that more than 5% of adults experience some kind of vertigo each year. in 80% of affected individuals, this symptom resulted in a medical consultation, interruption of daily activities, or sick leave. therefore, vertigo can have a significant impact on health and well being. unfortunately, there is not yet any satisfactory objective method for diagnosis of vertigo. at present, the diagnosis usually depends on medical history, vestibular function tests, dix-hallpike positioning tests done in the office, and, to some extent imaging studies doen to look for such abnormalities such as acoustic tumor, brain tumor, and evidence of multiple sclerosis. a number of recent studies support the possibility of using functional mri (fmri), particularly a new diffusion tensor fiber tracking (dtt) technique, as a new tool for diagnosis of disorders that can cause vertigo. in this study, our hypothesis is that there is an alteration in the activity in neural pathways of patients with vertigo that can be detected by fmri. to test this assumption, our objective in this study is to determine whether there is a difference between the fmri images obtained in normal subjects versus those in patients with vertigo.

Eligibility criteria:
inclusion criteria: * healthy volunteer or patient with symptom of vertigo exclusion criteria: * evidence of mental impairment * any type of bioimplant or any type of ferromagnetic bioimplant * pregnant females * exhibit noticeable anxiety and/or claustrophobia * history of serious disease in central nervous and cerebrovascular systems.

Keywords: functional magnetic resonance imaging vertigo vestibular
predictors of postoperative complications and readmissions in laparoscopic pancreas resection

Conditions: Laparoscopic Surgery; Pancreas

Summary: laparoscopic resection of the pancreas has become widely accepted in the treatment of lesions which are benign or of low-grade malignancy. the objective of this study is to analyze the factors that predict postoperative complications and hospital readmission in a series of laparoscopic pancreatectomies.

the investigators conducted a retrospective study using a prospective database of laparoscopic resections performed between 2000 and 2020. data were collected on age, gender, body mass index (bmi), american society of anesthesiology (asa) score, type of surgery, histologic type, operative time, hospital stay, postoperative complications, degree of severity and hospital readmission

Eligibility criteria:
inclusion criteria: * a retrospective study was carried out using data from a prospective database of all consecutive patients undergoing laparoscopic resection of the pancreas between 2000 and 2020 in the clínica universidad de navarra exclusion criteria: * n/a
pharmacokinetic study of busulfan in allogeneic stem cell transplantation in adult patients with acute leukemia

Conditions: Acute Leukemia

Summary: intravenous busulfan (iv-bu) is commonly used as part of preparation regimen for allogeneic hematopoietic stem cell transplantation for patients with acute leukemia. though the pharmacokinetics data are available for population from america, europe and japan or korea in asia, there are no data in chinese population. it is shown that high bu concentration are associated with the toxicity such as veno-occlusion disease and lower concentration is correlated with reduced anti-leukemia effect, thus the monitoring of bu and/or the strategy to achieve an optimal target bu concentration are accepted to avoid toxicity while maintain the anti-leukemia effect which may overall improve the outcome of allo-sct. thus we conduct the pharmacokinetic study in chinese population.

all patients received intravenous busulfan based conditioning regimen for allogeneic stem cell transplantation. intravenous busulfan (iv-bu) was given 1.6mg/kg twice daily for 4 days as in the conditioning regimen. blood samples were obtained after first and 7th dose of iv bulsulfan.

Eligibility criteria:
inclusion criteria: * patient with acute myeloid or lymphoblastic leukemia in 1st or second remission * age 18-55 years * with inform consent * no contraindication for allogeneic transplantation: active infection, allergy to flu/bu/ctx, liver and renal function damage * hla matched related (6/6) or unrelated donors (at least 8/10) exclusion criteria: * age less than 18 years or over 56 years * hla mismatched related donor * liver function/renal function damage (over 2 x upper normal range) * with mental disease

Keywords: acute leukemia allogeneic stem cell transplantation busulfan
study to evaluate the efficacy and safety of tegoprazan in erd patients with nighttime heartburn and sleep disturbance

Conditions: Erosive Reflux Disease

Summary: this study aims to compare the nighttime heartburn and sleep disturbance improvement effect of tegoprazan 50mg and eomeprazole 40mg in patients with erd patients.

this is a multi-center, double-blind, randomized, active-controlled phase 4 (pilot) study. subjects will be randomly assigned to one of the two treatment groups (tegoprazan 50mg, esomeprazole 40mg)

Eligibility criteria:
inclusion criteria: 1. subjects aged between 19 and 75 years 2. subjects who have erosive reflux disease exclusion criteria: 1. unable to undergo upper gi endoscopy 2. symptoms of primary or secondary esophageal movement disorders 3. planning or perform surgery that can affect gastric acid secretion (e.g., upper gastrectomy, vagotomy, etc.)
randomized study of botulinum toxin type a for achalasia

Conditions: Esophageal Achalasia

Summary: objectives: i. compare the efficacy of two doses of botulinum toxin in the treatment of achalasia. ii. compare the safety of these two doses in these patients.

protocol outline: this is a randomized, double blind, dose response study. patients are randomized to one of two treatment arms; each arm receives a different dose of botulinum toxin type a. all patients undergo a flexible upper gastrointestinal endoscopy. botulinum toxin is injected into the lower esophageal sphincter into each of 4 quadrants. some patients may receive a second treatment, depending on response and/or time of relapse. patients are followed daily for 7 days, then every 1-6 months for 1-2 years after treatment. completion date provided represents the completion date of the grant per oopd records

Eligibility criteria:
protocol entry criteria: --disease characteristics-- * diagnosis of achalasia by esophageal manometry and upper endoscopy * symptomatic including dysphagia, regurgitation, etc. * no esophageal ulcers, barrett's esophagus, significant esophagitis, or esophageal varices --patient characteristics-- * hematopoietic: platelet count at least 50,000/mm3 * hepatic: pt no greater than 3 seconds no severe hepatic problems * renal: no severe renal problems * cardiovascular: no recent myocardial infarction no unstable angina no decompensated congestive heart failure * pulmonary: no severe pulmonary disease with dyspnea at rest * other: no altered mental status no serious systemic disease not pregnant

Keywords: achalasia gastrointestinal disorders rare disease
a study of multiple doses of ly2922470 in participants with diabetes

Conditions: Diabetes Mellitus, Type 2

Summary: the main purpose of this study is to determine the safety of ly2922470, taken as oral capsules, once or twice daily for approximately 28 days, in participants with diabetes. it also aims to determine how long the drug stays in the body and how it affects blood sugar levels. a screening appointment is required within 28 days before the start of the study and a follow up appointment is required approximately 14 days after the last study dose is taken.


Eligibility criteria:
inclusion criteria: * must be a male, or a female who cannot become pregnant, and who has type 2 diabetes * have a glycated hemoglobin (hba1c) value of greater than or equal to 6.5% and less than or equal to 11% at screening * do not have any change to their diabetes treatment (exercise with or without metformin) for at least 4 weeks prior to screening * have a screening body mass index (bmi) of 18.0 to 45.0 kilograms per square meter (kg/m\^2) * have blood pressure, pulse rate, blood and urine laboratory test results acceptable for the study exclusion criteria: * are currently participating in another clinical study or completed one in the last 30 days * have a history of significant heart, lung, liver, kidney, stomach or brain disease, or have any medical problems which may cause an increased risk during the study * have electrocardiogram (ecg) readings that are not suitable for the study * are infected with hepatitis b or hepatitis c * are infected with human immunodeficiency virus (hiv) * have donated blood equal to or more than 500 ml within 56 days before the first dose of drug or have donated plasma within 7 days before the first dose or provided any blood donation within the last month from screening
clinical intramuscular gene transfer trial of raavrh74.mck.micro-dystrophin to patients with duchenne muscular dystrophy

Conditions: Duchenne Muscular Dystrophy

Summary: the proposed phase i clinical trial is a pilot study to evaluate safety and biological activity of the raavrh74.mck.micro-dystrophin vector administered by an intramuscular route. this study will evaluated the micro-dystrophin vector as a potential dystrophin replacement mechanism for duchenne muscular dystrophy. two cohorts will undergo gene transfer in a standard three-six dose escalation scheme to establish maximum tolerated dose (mtd) using toxicity. a minimum of three subjects will be enrolled into each cohort. the first cohort will receive a total dose of 3e11 vg. the second cohort will receive 1e12 vg total dose.

the primary objective of this study is the assessment of the safety of an intramuscular administration of raavrh74.mck.micro-dystrophin to the extensor digitorum brevis (edb) muscle of patients with duchenne muscular dystrophy (dmd). safety will be assessed by changes in hematology, serum chemistry, urinalysis, immunologic response to raavrh74 and micro-dystrophin protein, and reported history and observations of symptoms. subjects will be evaluated at baseline, injection visit (days 0-2), and return for follow up visits on days 7, 14, 30,60, 90, and 180 and at the end of 1st and 2nd years. on day 180, subjects will undergo a muscle biopsy on the injected muscles in one foot compared with placebo-treatment in the opposite foot to establish transgene expression and any potential toxicity from gene transfer.

Eligibility criteria:
inclusion criteria: * age 7 or older; must be wheelchair-dependent * confirmed dystrophin mutations based on mutation compatibility with micro-dys cdna based on previously published methods. * males of any ethnic group will be eligible. * ability to cooperate with muscle testing. * willingness of sexually active subjects with reproductive capacity to practice reliable method of contraception (if appropriate). exclusion criteria: * active viral infection based on clinical observations. * symptoms or signs of cardiomyopathy, including: * dyspnea on exertion, pedal edema, shortness of breath upon lying flat, or rales at the base of the lungs * echocardiogram with ejection fraction below 40% * serological evidence of hiv infection, or hepatitis a, b or c infection * diagnosis of (or ongoing treatment for) an autoimmune disease * concomitant illness or requirement for chronic drug treatment that in the opinion of the pi creates unnecessary risks for gene transfer. * subjects with aavrh74 binding antibody titers ≥ 1:50 as determined by elisa immunoassay. * abnormal laboratory values in the clinically significant range as defined in protocol or based upon normal values in the nationwide children's hospital laboratory.

Keywords: dmd muscular dystrophy dystrophin